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首页> 外文期刊>Journal of empirical research on human research ethics : >Regulatory Support Improves Subsequent IRB Approval Rates in Studies Initially Deemed Not Ready for Review: A CTSA Institution’s Experience
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Regulatory Support Improves Subsequent IRB Approval Rates in Studies Initially Deemed Not Ready for Review: A CTSA Institution’s Experience

机译：监管支持提高了后续的IRB批准率，最初认为尚未准备好审查：CTSA机构的经验

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摘要

We evaluated the impact of a regulatory support service (known as the Regulatory Knowledge and Support [RKS] program), part of the Medical University of South Carolina’s Clinical and Translational Science Award, on the success of Institutional Review Board (IRB) applications that have previously been deemed by the IRB to be Not Ready for Review (NRR). At the time of this evaluation, 77 studies had been deemed NRR, 53 of which came from trainees and junior faculty. All the applications that received regulatory support either received IRB approval or were deemed to not be research, and therefore did not require IRB review. In all, 39.1% (n = 18) of the research teams who did not accept regulatory support successfully received IRB approval. Providing regulatory support, particularly to trainees and junior faculty, may be associated with better success in obtaining IRB approval as well as preventing the unnecessary submission of projects that are not research and would therefore not require IRB review or approval.
机译：我们评估了监管支持服务的影响（称为监管知识和支持[RKS]计划），部分南卡罗来纳州临床和翻译科学奖的一部分，依据制度审查委员会（IRB）申请的成功以前被IRB被视为尚未准备好审查（NRR）。在这种评估时，77项研究被认为是NRR，其中53名来自学员和初级教师。收到监管支持的所有申请要么收到IRB批准，或被视为不是研究，因此不需要IRB审查。总之，39.1％（n = 18）的研究团队没有接受监管支持成功获得IRB批准。提供监管支持，特别是对学员和初级学院，可能在获得IRB批准方面取得更好的成功，并防止不必提交未经研究的项目，因此不需要IRB审查或批准。

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